NCT00720954

Brief Summary

The aim of this study is to compare the rigid thoracoscopy with CT-guided pleural needle biopsy by the diagnostic efficacy and safety in patients with pleural effusion.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2008

Completed
Last Updated

July 23, 2008

Status Verified

July 1, 2008

Enrollment Period

2.4 years

First QC Date

July 21, 2008

Last Update Submit

July 22, 2008

Conditions

Pleural EffusionPleural Diseases

Keywords

ThoracoscopyPleural needle biopsyMalignant pleural diseasesMesotheliomaDiagnosisPleurisy tuberculosisPatients with pleural diseases and pleural effusion should have been included in the study.

Outcome Measures

Primary Outcomes (1)

  • Efficacy and safety of both thoracoscopy and CT-guided pleural needle biopsy for diagnosis of pleural diseases

    30 months

Secondary Outcomes (1)

  • Determine the efficacy of pleural needle biopsy and thoracoscopy in relation to CT findings.

    30 months

Study Arms (2)

A

OTHER

CT guided pleural needle biopsy

Procedure: Ct-guided pleural needle biopsy

B

OTHER

Thoracoscopy

Procedure: Thoracoscopy

Interventions

Ct-guided pleural needle biopsyPROCEDURE

Biopsy of pleura

Also known as: Diagnose
A
ThoracoscopyPROCEDURE

Biopsy of pleura

Also known as: Diagnose
B

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages between 18-85
  • Pleural effusion in conventional radiography
  • At least 10x10 cm space in pleural space with effusion
  • No bleeding diathesis
  • Informed consent

You may not qualify if:

  • Patients who went under pleural biopsy before
  • Arrythmia
  • Hypertensive attack during biopsy
  • Bleeding diathesis
  • Hypoxemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ESOGU MEDICAL FACULTY DEPARTMENT of CHEST DISEASES

Eskişehir, 26220, Turkey (Türkiye)

Location

Related Publications (1)

  • Metintas M, Ak G, Dundar E, Yildirim H, Ozkan R, Kurt E, Erginel S, Alatas F, Metintas S. Medical thoracoscopy vs CT scan-guided Abrams pleural needle biopsy for diagnosis of patients with pleural effusions: a randomized, controlled trial. Chest. 2010 Jun;137(6):1362-8. doi: 10.1378/chest.09-0884. Epub 2010 Feb 12.

    PMID: 20154079DERIVED

Related Links

MeSH Terms

Conditions

Pleural EffusionPleural DiseasesMesotheliomaDisease

Interventions

Clinical Laboratory TechniquesThoracoscopy

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, MesothelialPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 21, 2008

First Posted

July 23, 2008

Study Start

January 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

July 23, 2008

Record last verified: 2008-07

Locations

TU(1)